Non-invasive nerve stimulation

ABSTRACT

A topical nerve stimulator patch and system are provided including a dermal patch; an electrical signal generator associated with the patch; a signal receiver to activate the electrical signal generator; a power source for the electrical signal generator associated with the patch; an electrical signal activation device; and a nerve feedback sensor.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/912,058, filed on Mar. 5, 2018, which claims priority of U.S.Provisional Patent Application Ser. No. 62/582,634, filed on Nov. 7,2017 and U.S. Provisional Patent Application Ser. No. 62/574,625, filedon Oct. 19, 2017. The disclosure of each of these applications is herebyincorporated by reference.

FIELD

This invention pertains to the activation of nerves by topicalstimulators to control or influence muscles, tissues, organs, orsensation, including pain, in humans and mammals.

BACKGROUND INFORMATION

Nerve disorders may result in loss of control of muscle and other bodyfunctions, loss of sensation, or pain. Surgical procedures andmedications sometimes treat these disorders but have limitations. Thisinvention pertains to a system for offering other options for treatmentand improvement of function.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a depiction of a neuron activating a muscle by electricalimpulse.

FIG. 2 is a representation of the electrical potential activation timeof an electrical impulse in a nerve.

FIG. 3 is a cross section of a penis.

FIG. 4 is an illustration of a Topical Nerve Stimulator/Sensor (TNSS)component configuration including a system on a chip (SOC).

FIG. 5 is an illustration of the upper side of a Smart Band Aidimplementation of a TNSS showing location of battery, which may be ofvarious types.

FIG. 6 is a an illustration of the lower side of the SBA of FIG. 5 .

FIG. 7 is TNSS components incorporated into a SBA.

FIG. 8 is examples of optional neural stimulator and sensor chip setsincorporated into a SBA.

FIG. 9 is examples of optional electrode configurations for a SBA.

FIG. 10 is an example of the use of TNSS with a Control Unit as aSystem, in a population of Systems and software applications.

FIG. 11 shows a method for forming and steering a beam by the user of aplurality of radiators.

FIG. 12 is an exemplary beam forming and steering mechanism.

FIG. 13 illustrates exemplary Control Units for activating a nervestimulation device.

FIG. 14 are exemplary software platforms for communicating between theControl Units and the TNSS, gathering data, networking with other TNSSs,and external communications.

FIG. 15 represents TNSS applications for patients with spinal cordinjury.

FIG. 16 shows an example TNSS system.

FIG. 17 shows communications among the components of the TNSS system ofFIG. 16 and a user.

FIG. 18 shows an example electrode configuration for electric fieldsteering and sensing.

FIG. 19 shows an example of stimulating and sensing patterns of signalsin a volume of tissue.

FIG. 20 is a graph showing pulses applied to the skin.

FIG. 21 is a graph showing symmetrical and asymmetrical pulses appliedto the skin.

FIG. 22 is a cross-sectional diagram showing a field in underlyingtissue produced by application of two electrodes to the skin.

FIG. 23 is a cross-sectional diagram showing a field in underlyingtissue produced by application of two electrodes to the skin, with twolayers of tissue of different electrical resistivity.

FIG. 24 is a cross-sectional diagram showing a field in underlyingtissue when the stimulating pulse is turned off.

FIG. 25A is a system diagram of an example software and hardwarecomponents showing an example of a Topical Nerve Stimulator/Sensor(TNSS) interpreting a data stream from a control device in accordancewith one example.

FIG. 25B is a flow chart showing an example of a function of a mastercontrol program in accordance with one example.

FIG. 26 is a block diagram of an example TNSS component configurationincluding a system on a chip (SOC) in accordance with one example.

FIG. 27 is a flow diagram of the protocol for adaptive current controlin accordance with one example.

FIG. 28 is a Differential Integrator Circuit used in the AdaptiveCurrent Protocol in accordance with one example.

FIG. 29 is a table relating charge duration vs. frequency to providefeedback to the Adaptive Current Protocol in accordance with oneexample.

FIG. 30 is a tibial patch or TNSS or SmartPad designed in a shape toconform to the skin in accordance with one example.

FIG. 31 is a tibial patch or TNSS or SmartPad designed in a shape toconform to the skin in accordance with other examples.

FIG. 32 is a skin patch that includes a SmartPad with TNSS design andpackaging in accordance with one example.

FIG. 33 illustrates other example locations for a patch.

FIG. 34 illustrates a cutaway view where a right foot plantar sock patchis affixed into the sole of a sock in accordance with one example.

FIG. 35 illustrates a cutaway view where a right foot plantar shoe patchis affixed into the sole of a shoe in accordance with one example

DETAILED DESCRIPTION

A method for electrical, mechanical, chemical and/or optical interactionwith a human or mammal nervous system to stimulate and/or record bodyfunctions using small electronic devices attached to the skin andcapable of being wirelessly linked to and controlled by a cellphone,activator or computer network.

The body is controlled by a chemical system and a nervous system. Nervesand muscles produce and respond to electrical voltages and currents.Electrical stimulation of these tissues can restore movement or feelingwhen these have been lost, or can modify the behavior of the nervoussystem, a process known as neuro modulation. Recording of the electricalactivity of nerves and muscles is widely used for diagnosis, as in theelectrocardiogram, electromyogram, electroencephalogram, etc. Electricalstimulation and recording require electrical interfaces for input andoutput of information. Electrical interfaces between tissues andelectronic systems are usually one of three types:

a. Devices implanted surgically into the body, such as pacemakers. Theseare being developed for a variety of functions, such as restoringmovement to paralyzed muscles or restoring hearing, and can potentiallybe applied to any nerve or muscle. These are typically specialized andsomewhat expensive devices.

b. Devices inserted temporarily into the tissues, such as needles orcatheters, connected to other equipment outside the body. Health carepractitioners use these devices for diagnosis or short-term treatment.

c. Devices that record voltage from the surface of the skin fordiagnosis and data collection, or apply electrical stimuli to thesurface of the skin using adhesive patches connected to a stimulator.Portable battery-powered stimulators have typically been simple devicesoperated by a patient, for example for pain relief. Their use has beenlimited by;

i. The inconvenience of chronically managing wires, patches andstimulator, particularly if there are interfaces to more than one site,and

ii. The difficulty for patients to control a variety of stimulusparameters such as amplitude, frequency, pulse width, duty cycle, etc.

Nerves can also be stimulated mechanically to produce sensation orprovoke or alter reflexes; this is the basis of touch sensation andtactile feedback. Nerves can also be affected chemically by medicationsdelivered locally or systemically and sometimes targeted to particularnerves on the basis of location or chemical type. Nerves can also bestimulated or inhibited optically if they have had genes inserted tomake them light sensitive like some of the nerves in the eye. Theactions of nerves also produce electrical, mechanical and chemicalchanges that can be sensed.

The topical nerve stimulator/sensor (TNSS) is a device to stimulatenerves and sense the actions of the body that can be placed on the skinof a human or mammal to act on and respond to a nerve, muscle or tissue.One implementation of the TNSS is the Smart Band Aid™ (SBA). A system,incorporating a SBA, controls neuro modulation and neuro stimulationactivities. It consists of one or more controllers or Control Units, oneor more TNSS modules, software that resides in Control Units and TNSSmodules, wireless communication between these components, and a datamanaging platform. The controller hosts software that will control thefunctions of the TNSS. The controller takes inputs from the TNSS of dataor image data for analysis by said software, The controller provides aphysical user interface for display to and recording from the user, suchas activating or disabling the TNSS, logging of data and usagestatistics, generating reporting data. Finally, the controller providescommunications with other Controllers or the Internet cloud.

The controller communicates with the Neurostim module, also called TNSSmodule or SBA, and also communicates with the user. In at least oneexample, both of these communications can go in both directions, so eachset of communications is a control loop. Optionally, there may also be acontrol loop directly between the TNSS module and the body. So thesystem optionally may be a hierarchical control system with at leastfour control loops. One loop is between the TNSS and the body; anotherloop is between the TNSS and the controller; another loop is between thecontroller and the user; and another loop is between the controller andother users via the cloud. Each control loop has several functionsincluding: (1) sending activation or disablement signals between thecontroller and the TNSS via a local network such as Bluetooth; (2)driving the user interface, as when the controller receives commandsfrom the user and provides visual, auditory or tactile feedback to theuser; (3) analyzing TNSS data, as well as other feedback data such asfrom the user, within the TNSS, and/or the controller and/or or thecloud; (4) making decisions about the appropriate treatment; (5) systemdiagnostics for operational correctness; and (6) communications withother controllers or users via the Internet cloud for data transmissionor exchange, or to interact with apps residing in the Internet cloud.

The control loop is closed. This is as a result of having bothstimulating and sensing. The sensing provides information about theeffects of stimulation, allowing the stimulation to be adjusted to adesired level or improved automatically.

Typically, stimulation will be applied. Sensing will be used to measurethe effects of stimulation. The measurements sensed will be used tospecify the next stimulation. This process can be repeated indefinitelywith various durations of each part. For example: rapid cycling throughthe process (a-b-c-a-b-c-a-b-c); prolonged stimulation, occasionalsensing (aaaa-b-c-aaaa-b-c-aaaa-b-c); or prolonged sensing, occasionalstimulation (a-bbbb-c-a-bbbb-c-a-bbbb). The process may also start withsensing, and when an event in the body is detected this information isused to specify stimulation to treat or correct the event, for example,(bbbbbbbbb-c-a-bbbbbbbb-c-a-bbbbbbbbb). Other patterns are possible andcontemplated within the scope of the application.

The same components can be used for stimulating and sensing alternately,by switching their connection between the stimulating circuits and thesensing circuits. The switching can be done by standard electroniccomponents. In the case of electrical stimulating and sensing, the sameelectrodes can be used for both. An electronic switch is used to connectstimulating circuits to the electrodes and electric stimulation isapplied to the tissues. Then the electronic switch disconnects thestimulating circuits from the electrodes and connects the sensingcircuits to the electrodes and electrical signals from the tissues arerecorded.

In the case of acoustic stimulating and sensing, the same ultrasonictransducers can be used for both (as in ultrasound imaging or radar). Anelectronic switch is used to connect circuits to the transducers to sendacoustic signals (sound waves) into the tissues. Then the electronicswitch disconnects these circuits from the transducers and connectsother circuits to the transducers (to listen for reflected sound waves)and these acoustic signals from the tissues are recorded.

Other modalities of stimulation and sensing may be used (e.g. light,magnetic fields, etc.) The closed loop control may be implementedautonomously by an individual TNSS or by multiple TNSS modules operatingin a system such as that shown below in FIG. 16 . Sensing might becarried out by some TNSSs and stimulation by others.

Stimulators are protocol controlled initiators of electricalstimulation, where such protocol may reside in either the TNSS and/orthe controller and/or the cloud. Stimulators interact with associatedsensors or activators, such as electrodes or MEMS devices.

The protocol, which may be located in the TNSS, the controller or thecloud, has several functions including:

(1) Sending activation or disablement signals between the controller andthe TNSS via a local network such as Bluetooth. The protocol sends asignal by Bluetooth radio waves from the smartphone to the TNSS moduleon the skin, telling it to start or stop stimulating or sensing. Otherwireless communication types are possible.

(2) Driving the user interface, as when the controller receives commandsfrom the user and provides visual, auditory or tactile feedback to theuser. The protocol receives a command from the user when the usertouches an icon on the smartphone screen, and provides feedback to theuser by displaying information on the smartphone screen, or causing thesmartphone to beep or buzz.

(3) Analyzing TNSS data, as well as other feedback data such as from theuser, within the TNSS, and/or the controller and/or or the cloud. Theprotocol analyzes data sensed by the TNSS, such as the position of amuscle, and data from the user such as the user's desires as expressedwhen the user touches an icon on the smartphone; this analysis can bedone in the TNSS, in the smartphone, and/or in the cloud.

(4) Making decisions about the appropriate treatment. The protocol usesthe data it analyzes to decide what stimulation to apply.

(5) System diagnostics for operational correctness. The protocol checksthat the TNSS system is operating correctly.

(6) Communications with other controllers or users via the Internetcloud for data transmission or exchange, or to interact with appsresiding in the Internet cloud. The protocol communicates with othersmartphones or people via the internet wirelessly; this may includesending data over the internet, or using computer programs that areoperating elsewhere on the internet.

A neurological control system, method and apparatus are configured in anecosystem or modular platform that uses potentially disposable topicaldevices to provide interfaces between electronic computing systems andneural systems. These interfaces may be direct electrical connectionsvia electrodes or may be indirect via transducers (sensors andactuators). It may have the following elements in variousconfigurations: electrodes for sensing or activating electrical eventsin the body; actuators of various modalities; sensors of variousmodalities; wireless networking; and protocol applications, e.g. fordata processing, recording, control systems. These components areintegrated within the disposable topical device. This integration allowsthe topical device to function autonomously. It also allows the topicaldevice along with a remote control unit (communicating wirelessly via anantenna, transmitter and receiver) to function autonomously.

Referring to FIG. 1 , nerve cells are normally electrically polarizedwith the interior of the nerve being at an electric potential 70 mVnegative relative to the exterior of the cell. Application of a suitableelectric voltage to a nerve cell (raising the resting potential of thecell from −70 mV to above the firing threshold of −55 mV) can initiate asequence of events in which this polarization is temporarily reversed inone region of the cell membrane and the change in polarization spreadsalong the length of the cell to influence other cells at a distance,e.g. to communicate with other nerve cells or to cause or prevent musclecontraction.

Referring to FIG. 2 , a nerve impulse is graphically represented from apoint of stimulation resulting in a wave of depolarization followed by arepolarization that travels along the membrane of a neuron during themeasured period. This spreading action potential is a nerve impulse. Itis this phenomenon that allows for external electrical nervestimulation.

Referring to FIG. 3 , the dorsal genital nerve on the back of the penisor clitoris just under the skin is a purely sensory nerve that isinvolved in normal inhibition of the activity of the bladder duringsexual activity, and electrical stimulation of this nerve has been shownto reduce the symptoms of the Over Active Bladder. Stimulation of theunderside of the penis may cause sexual arousal, erection, ejaculationand orgasm.

A Topical nerve stimulator/sensor (TNSS) is used to stimulate thesenerves and is convenient, unobtrusive, self-powered, controlled from asmartphone or other control device. This has the advantage of beingnon-invasive, controlled by consumers themselves, and potentiallydistributed over the counter without a prescription.

Referring to FIG. 4 , the TNSS has one or more electronic circuits orchips that perform the functions of: communications with the controller,nerve stimulation via electrodes 408 that produce a wide range ofelectric field(s) according to treatment regimen, one or more antennae410 that may also serve as electrodes and communication pathways, and awide range of sensors 406 such as, but not limited to, mechanical motionand pressure, temperature, humidity, chemical and positioning sensors.One arrangement would be to integrate a wide variety of these functionsinto an SOC, system on chip 400. Within this is shown a control unit 402for data processing, communications and storage and one or morestimulators 404 and sensors 406 that are connected to electrodes 408. Anantenna 410 is incorporated for external communications by the controlunit. Also present is an internal power supply 412, which may be, forexample, a battery. An external power supply is another variation of thechip configuration. It may be necessary to include more than one chip toaccommodate a wide range of voltages for data processing andstimulation. Electronic circuits and chips will communicate with eachother via conductive tracks within the device capable of transferringdata and/or power.

In one or more examples, a Smart Band Aid™ incorporating a battery andelectronic circuit and electrodes in the form of adhesive conductivepads may be applied to the skin, and electrical stimuli is passed fromthe adhesive pads into the tissues. Stimuli may typically be trains ofvoltage-regulated square waves at frequencies between 15 and 50 Hz withcurrents between 20 and 100 mA. The trains of stimuli are controlledfrom a smartphone operated by the user. Stimuli may be either initiatedby the user when desired, or programmed according to a timed schedule,or initiated in response to an event detected by a sensor on the SmartBand Aid™ or elsewhere. Another implementation for males may be a TNSSincorporated in a ring that locates a stimulator conductively toselected nerves in a penis to be stimulated.

Referring to FIG. 5 , limited lifetime battery sources will be employedas internal power supply 412, to power the TNSS deployed in thisillustration as a Smart Band Aid™. These may take the form of LithiumIon technology or traditional non-toxic Mn02 technologies. FIG. 5illustrates different battery options such as a printable ManganeseOxide battery 516 and a button battery 518. A TNSS of different shapesmay require different battery packaging.

FIG. 6 shows an alternate arrangement of these components where thebatteries 616-618 are positioned on the bottom side of the SBA betweenthe electrodes 610 and 620. In this example, battery 616 is a lithiumion battery, battery 617 is a Mn02 battery and battery 618 is a buttonbattery. Other types of batteries and other battery configurations arepossible within the scope of this application in other examples.

Aside from the Controller, the Smart Band Aid™ Packaging Platformconsists of an assembly of an adhesive patch capable of being applied tothe skin and containing the TNSS Electronics, protocol, and powerdescribed above.

Referring to FIG. 7 is a TNSS deployed as a Smart Band Aid™ 414. TheSmart Band Aid™ has a substrate with adhesive on a side for adherence toskin, the SOC 400 previously described in FIG. 4 , or electronicpackage, and electrodes 408 disposed between the dermis and the adhesivesurface. The electrodes provide electrical stimuli through the dermis tonerves and other tissue and in turn may collect electrical signals fromthe body, such as the electrical signals produced by muscles when theycontract (the electromyogram) to provide data about body functions suchas muscle actions.

Referring to FIG. 8 , different chips may be employed to designrequirements. Shown are sample chips for packaging in a TNSS in thisinstance deployed as a SBA. For example, neural stimulator 800, sensor802, processor/communications 804 are represented. The chips can bepackaged separately on a substrate, including a flexible material, or asa system-on-chip (SOC) 400. The chip connections and electronics packageare not shown but are known in the art.

Referring to FIG. 9 , SBAs with variations on arrangements of electrodesare shown. Each electrode may consist of a plurality of conductivecontacts that give the electrode abilities to adjust the depth,directionality, and spatial distribution of the applied electric field.For all the example electrode configurations shown, 901-904, the depthof the electrical stimulation can be controlled by the voltage and powerapplied to the electrode contacts. Electric current can be applied tovarious electrode contacts at opposite end of the SBA, or within aplurality of electrode contacts on a single end of the SBA. The phaserelationship of the signals applied to the electrode contacts can varythe directionality of the electric field. For all configurations ofelectrodes, the applied signals can vary over time and spatialdimensions. The configuration on the left, 901, shows a plurality ofconcentric electrode contacts at either end of the SBA. Thisconfiguration can be used to apply an electric stimulating field atvarious tissue depths by varying the power introduced to the electrodecontacts. The next configuration, 902, shows electrodes 404 that arearranged in a plurality of parallel strips of electrical contacts. Thisallows the electric field to be oriented perpendicular or parallel tothe SBA. The next configuration, 903, shows an example matrix ofelectrode contacts where the applied signal can generate a stimulatingfield between any two or more electrode contacts at either end of theSBA, or between two or more electrode contacts within a single matrix atone end of the SBA. Finally, the next configuration on the far right,904, also shows electrodes that are arranged in a plurality of parallelstrips of electrical contacts. As with the second configuration, thisallows the electric field to be oriented perpendicular or parallel tothe SBA. There may be many other arrangements of electrodes andcontacts.

One or more TNSSs with one or more Controllers form a System. Systemscan communicate and interact with each other and with distributedvirtualized processing and storage services. This enables the gathering,exchange, and analysis of data among populations of systems for medicaland non-medical applications.

Referring to FIG. 10 , a system is shown with two TNSS units 1006, withone on the wrist, one on the leg, communicating with its controller, asmartphone 1000 or other control device. The TNSS units can be bothsensing and stimulating and can act independently and also work togetherin a Body Area Network (BAN). Systems communicate with each other over acommunication bridge or network such as a cellular network. Systems alsocommunicate with applications running in a distributed virtualizedprocessing and storage environment generally via the Internet 1002. Thepurpose for communications with the distributed virtualized processingand storage

environment is to communicate large amounts of user data for analysisand networking with other third parties such as hospitals, doctors,insurance companies, researchers, and others. There are applicationsthat gather, exchange, and analyze data from multiple Systems 1004.Third party application developers can access TNSS systems and theirdata to deliver a wide range of applications. These applications canreturn data or control signals to the individual wearing the TNSS unit1006. These applications can also send data or control signals to othermembers of the population who employ systems 1008. This may represent anindividual's data, aggregated data from a population of users, dataanalyses, or supplementary data from other sources.

Referring to FIG. 11 , shown is an example of an electrode array toaffect beam forming and beam steering. Beam forming and steering allowsa more selective application of stimulation energy by a TNSS to nervesand tissue. Beam steering also provides the opportunity for lower powerfor stimulation of cells including nerves by applying the stimulatingmechanism directionally to a target. In the use of an electrical beamlower power demand lengthens battery life and allows for use of lowpower chip sets. Beam steering may be accomplished in multiple ways forinstance by magnetic fields and formed gates. FIG. 11 shows a method forforming and steering a beam by the use of a plurality of radiators 1102which are activated out of phase with each other by a plurality of phaseshifters 1103 that are supplied power from a common source 1104. Becausethe radiated signals are out of phase they produce an interferencepattern 1105 that results in the beam being formed and steered invarying controlled directions 1106. Electromagnetic radiation like lightshows some properties of waves and can be focused on certain locations.This provides the opportunity to stimulate tissues such as nervesselectively. It also provides the opportunity to focus the transmissionof energy and data on certain objects, including topical or implantedelectronic devices, thereby not only improving the selectivity ofactivating or controlling those objects but also reducing the overallpower required to operate them.

FIG. 12 is another example of a gating structure 1200 used for beamshaping and steering 1202. The gating structure 1200 shows an example ofan interlocked pair of electrodes that can be used for simple beamforming through the application of time-varying voltages. The steering1202 shows a generic picture of the main field lobes and how such beamsteering works in this example. FIG. 12 is illustrative of a possibleexample that may be used.

The human and mammal body is an anisotropic medium with multiple layersof tissue of varying electrical properties. Steering of an electricfield may be accomplished using multiple electrodes, or multiple SBAs,using the human or mammal body as an anisotropic volume conductor.Electric field steering will discussed below with reference to FIGS. 18and 19 .

Referring to FIG. 13 , the controller is an electronics platform that isa smartphone 1300, tablet 1302, personal computer 1304, or dedicatedmodule 1306 that hosts wireless communications capabilities, such asNear Field Communications, Bluetooth, or Wi-Fi technologies as enabledby the current set of communications chips, e.g. Broadcom BCM4334, TIWiLink 8 and others, and a wide range of protocol apps that cancommunicate with the TNSSs. There may be more than one controller,acting together. This may occur, for example, if the user has both asmartphone control app running, and a key fob controller in his/herpocket/purse.

TNSS protocol performs the functions of communications with thecontroller including transmitting and receiving of control and datasignals, activation and control of the neural stimulation, datagathering from on board sensors, communications and coordination withother TNSSs, and data analysis. Typically the TNSS may receive commandsfrom the controller, generate stimuli and apply these to the tissues,sense signals from the tissues, and transmit these to the controller. Itmay also analyze the signals sensed and use this information to modifythe stimulation applied. In addition to communicating with thecontroller it may also communicate with other TNSSs using electrical orradio signals via a body area network.

Referring to FIG. 14 , controller protocol executed and/or displayed ona smartphone 1400, tablet 1402 or other computing platform or mobiledevice, will perform the functions of communications with TNSS modulesincluding transmitting and receiving of control and data signals,activation and control of the neuro modulation regimens, data gatheringfrom on board sensors, communications and coordination with othercontrollers, and data analysis. In some cases local control of the neuromodulation regimens may be conducted by controller protocol withoutcommunications with the user.

FIG. 15 shows potential applications of electrical stimulation andsensing for the body, particularly for users who may suffer fromparalysis or loss of sensation or altered reflexes such as spasticity ortremor due to neurological disorders and their complications, as well asusers suffering from incontinence, pain, immobility and aging. Differentexample medical uses of the present system are discussed below.

FIG. 16 shows the components of one example of a typical TNSS system1600. TNSS devices 1610 are responsible for stimulation of nerves andfor receiving data in the form of electrical, acoustic, imaging,chemical and other signals which then can be processed locally in theTNSS or passed to the Control Unit 1620. TNSS devices 1610 are alsoresponsible for analysis and action. The TNSS device 1610 may contain aplurality of electrodes for stimulation and for sensing. The sameelectrodes may be used for both functions, but this is not required. TheTNSS device 1610 may contain an imaging device, such as an ultrasonictransducer to create acoustic images of the structure beneath theelectrodes or elsewhere in the body that may be affected by the neuralstimulation.

In this example TNSS system, most of the data gathering and analysis isperformed in the Control Unit 1620. The Control Unit 1620 may be acellular telephone or a dedicated hardware device. The Control Unit 1620runs an app that controls the local functions of the TNSS System 1600.The protocol app also communicates via the Internet or wireless networks1630 with other TNSS systems and/or with 3rd party softwareapplications.

FIG. 17 shows the communications among the components of the TNSS system1600 and the user. In this example, TNSS 1610 is capable of applyingstimuli to nerves 1640 to produce action potentials in the nerves 1640to produce actions in muscles 1670 or other organs such as the brain1650. These actions may be sensed by the TNSS 1610, which may act on theinformation to modify the stimulation it provides. This closed loopconstitutes the first level of the system 1600 in this example.

The TNSS 1610 may also be caused to operate by signals received from aControl Unit 1620 such as a cellphone, laptop, key fob, tablet, or otherhandheld device and may transmit information that it senses back to theControl Unit 1620. This constitutes the second level of the system 1600in this example.

The Control Unit 1620 is caused to operate by commands from a user, whoalso receives information from the Control Unit 1620. The user may alsoreceive information about actions of the body via natural senses such asvision or touch via sensory nerves and the spinal cord, and may in somecases cause actions in the body via natural pathways through the spinalcord to the muscles.

The Control Unit 1620 may also communicate information to other users,experts, or application programs via the Internet 1630, and receiveinformation from them via the Internet 1630.

The user may choose to initiate or modify these processes, sometimesusing protocol applications residing in the TNSS 1610, the Control Unit1620, the Internet 1630, or wireless networks. This software may assistthe user, for example by processing the stimulation to be delivered tothe body to render it more selective or effective for the user, and/orby processing and displaying data received from the body or from theInternet 1630 or wireless networks to make it more intelligible oruseful to the user.

FIG. 18 shows an example electrode configuration 1800 for Electric FieldSteering. The application of an appropriate electric field to the bodycan cause a nerve to produce an electrical pulse known as an actionpotential. The shape of the electric field is influenced by theelectrical properties of the different tissue through which it passesand the size, number and position of the electrodes used to apply it.The electrodes can therefore be designed to shape or steer or focus theelectric field on some nerves more than on others, thereby providingmore selective stimulation.

An example 10×10 matrix of electrical contacts 1860 is shown. By varyingthe pattern of electrical contacts 1860 employed to cause an electricfield 1820 to form and by time varying the applied electrical power tothis pattern of contacts 1860, it is possible to steer the field 1820across different parts of the body, which may include muscle 1870, bone,fat, and other tissue, in three dimensions. This electric field 1820 canactivate specific nerves or nerve bundles 1880 while sensing theelectrical and mechanical actions produced 1890, and thereby enablingthe TNSS to discover more effective or the most effective pattern ofstimulation for producing the desired action.

FIG. 19 shows an example of stimulating and sensing patterns of signalsin a volume of tissue. Electrodes 1910 as part of a cuff arrangement areplaced around limb 1915. The electrodes 1910 are external to a layer ofskin 1916 on limb 1915. Internal components of the limb 1915 includemuscle 1917, bone 1918, nerves 1919, and other tissues. By usingelectric field steering for stimulation, as described with reference toFIG. 18 , the electrodes 1910 can activate nerves 1919 selectively. Anarray of sensors (e.g., piezoelectric sensors ormicro-electro-mechanical sensors) in a TNSS can act as a phased arrayantenna for receiving ultrasound signals, to acquire ultrasonic imagesof body tissues. Electrodes 1910 may act as an array of electrodessensing voltages at different times and locations on the surface of thebody, with software processing this information to display informationabout the activity in body tissues, e.g., which muscles are activated bydifferent patterns of stimulation.

The SBA's ability to stimulate and collect organic data has multipleapplications including bladder control, reflex incontinence, sexualstimulations, pain control and wound healing among others. Examples ofSBA's application for medical and other uses follow.

Medical Uses

Bladder Management

Overactive bladder: When the user feels a sensation of needing to emptythe bladder urgently, he or she presses a button on the Controller toinitiate stimulation via a Smart Band Aid™ applied over the dorsal nerveof the penis or clitoris. Activation of this nerve would inhibit thesensation of needing to empty the bladder urgently, and allow it to beemptied at a convenient time.

Incontinence: A person prone to incontinence of urine because ofunwanted contraction of the bladder uses the SBA to activate the dorsalnerve of the penis or clitoris to inhibit contraction of the bladder andreduce incontinence of urine. The nerve could be activated continuously,or intermittently when the user became aware of the risk ofincontinence, or in response to a sensor indicating the volume orpressure in the bladder.

Erection, ejaculation and orgasm: Stimulation of the nerves on theunderside of the penis by a Smart Band Aid™ (electrical stimulation ormechanical vibration) can cause sexual arousal and might be used toproduce or prolong erection and to produce orgasm and ejaculation.

Pain control: A person suffering from chronic pain from a particularregion of the body applies a Smart Band Aid™ over that region andactivates electrically the nerves conveying the sensation of touch,thereby reducing the sensation of pain from that region. This is basedon the gate theory of pain.

Wound care: A person suffering from a chronic wound or ulcer applies aSmart Band Aid™ over the wound and applies electrical stimulicontinuously to the tissues surrounding the wound to accelerate healingand reduce infection.

Essential tremor: A sensor on a Smart Band Aid™ detects the tremor andtriggers neuro stimulation to the muscles and sensory nerves involved inthe tremor with an appropriate frequency and phase relationship to thetremor. The stimulation frequency would typically be at the samefrequency as the tremor but shifted in phase in order to cancel thetremor or reset the neural control system for hand position.

Reduction of spasticity: Electrical stimulation of peripheral nerves canreduce spasticity for several hours after stimulation. A Smart Band Aid™operated by the patient when desired from a smartphone could providethis stimulation.

Restoration of sensation and sensory feedback: People who lacksensation, for example as a result of diabetes or stroke use a SmartBand Aid™ to sense movement or contact, for example of the foot strikingthe floor, and the SBA provides mechanical or electrical stimulation toanother part of the body where the user has sensation, to improve safetyor function. Mechanical stimulation is provided by the use of acoustictransducers in the SBA such as small vibrators. Applying a Smart BandAid™ to the limb or other assistive device provides sensory feedbackfrom artificial limbs. Sensory feedback can also be used to substituteone sense for another, e.g. touch in place of sight.

Recording of mechanical activity of the body: Sensors in a Smart BandAid™ record position, location and orientation of a person or of bodyparts and transmit this data to a smartphone for the user and/or toother computer networks for safety monitoring, analysis of function andcoordination of stimulation.

Recording of sound from the body or reflections of ultrasound wavesgenerated by a transducer in a Smart Band Aid™ could provide informationabout body structure, e.g., bladder volume for persons unable to feeltheir bladder. Acoustic transducers may be piezoelectric devices or MEMSdevices that transmit and receive the appropriate acoustic frequencies.Acoustic data may be processed to allow imaging of the interior of thebody.

Recording of Electrical Activity of the Body

Electrocardiogram: Recording the electrical activity of the heart iswidely used for diagnosing heart attacks and abnormal rhythms. It issometimes necessary to record this activity for 24 hours or more todetect uncommon rhythms. A Smart Band Aid™ communicating wirelessly witha smartphone or computer network achieves this more simply than presentsystems.

Electromyogram: Recording the electrical activity of muscles is widelyused for diagnosis in neurology and also used for movement analysis.Currently this requires the use of many needles or adhesive pads on thesurface of the skin connected to recording equipment by many wires.Multiple Smart Band Aids™ record the electrical activity of many musclesand transmit this information wirelessly to a smartphone.

Recording of optical information from the body: A Smart Band Aid™incorporating a light source (LED, laser) illuminates tissues and sensesthe characteristics of the reflected light to measure characteristics ofvalue, e.g., oxygenation of the blood, and transmit this to a cellphoneor other computer network.

Recording of chemical information from the body: The levels of chemicalsor drugs in the body or body fluids is monitored continuously by a SmartBand Aid™ sensor and transmitted to other computer networks andappropriate feedback provided to the user or to medical staff. Levels ofchemicals may be measured by optical methods (reflection of light atparticular wavelengths) or by chemical sensors.

Special Populations of Disabled Users

There are many potential applications of electrical stimulation fortherapy and restoration of function. However, few of these have beencommercialized because of the lack of affordable convenient and easilycontrollable stimulation systems. Some applications are shown in theFIG. 15 .

Limb Muscle stimulation: Lower limb muscles can be exercised bystimulating them electrically, even if they are paralyzed by stroke orspinal cord injury. This is often combined with the use of a stationaryexercise cycle for stability. Smart Band Aid™ devices could be appliedto the quadriceps muscle of the thigh to stimulate these, extending theknee for cycling, or to other muscles such as those of the calf. Sensorsin the Smart Band Aid™ could trigger stimulation at the appropriate timeduring cycling, using an application on a smartphone, tablet, handheldhardware device such as a key fob, wearable computing device, laptop, ordesktop computer, among other possible devices. Upper limb muscles canbe exercised by stimulating them electrically, even if they areparalyzed by stroke of spinal cord injury. This is often combined withthe use of an arm crank exercise machine for stability. Smart Band Aid™devices are applied to multiple muscles in the upper limb and triggeredby sensors in the Smart Band Aids™ at the appropriate times, using anapplication on a smartphone.

Prevention of osteoporosis: Exercise can prevent osteoporosis andpathological fractures of bones. This is applied using Smart Band Aids™in conjunction with exercise machines such as rowing simulators, evenfor people with paralysis who are particularly prone to osteoporosis.

Prevention of deep vein thrombosis: Electric stimulation of the musclesof the calf can reduce the risk of deep vein thrombosis and potentiallyfatal pulmonary embolus. Electric stimulation of the calf muscles isapplied by a Smart Band Aid™ with stimulation programmed from asmartphone, e.g., during a surgical operation, or on a preset scheduleduring a long plane flight.

Restoration of Function (Functional Electrical Stimulation) Lower Limb

1) Foot drop: People with stroke often cannot lift their forefoot anddrag their toes on the ground. A Smart Band Aid™ is be applied justbelow the knee over the common peroneal nerve to stimulate the musclesthat lift the forefoot at the appropriate time in the gait cycle,triggered by a sensor in the Smart Band Aid™

2) Standing: People with spinal cord injury or some other paralyses canbe aided to stand by electrical stimulation of the quadriceps muscles oftheir thigh. These muscles are stimulated by Smart Band Aids™ applied tothe front of the thigh and triggered by sensors or buttons operated bythe patient using an application on a smartphone. This may also assistpatients to use lower limb muscles when transferring from a bed to achair or other surface.

3) Walking: Patients with paralysis from spinal cord injury are aided totake simple steps using electrical stimulation of the lower limb musclesand nerves. Stimulation of the sensory nerves in the common peronealnerve below the knee can cause a triple reflex withdrawal, flexing theankle, knee and hip to lift the leg, and then stimulation of thequadriceps can extend the knee to bear weight. The process is thenrepeated on the other leg. Smart Band Aids™ coordinated by anapplication in a smartphone produce these actions.

Upper Limb

Hand grasp: People with paralysis from stroke or spinal cord injury havesimple hand grasp restored by electrical stimulation of the muscles toopen or close the hand. This is produced by Smart Band Aids™ applied tothe back and front of the forearm and coordinated by sensors in theSmart Band Aids™ and an application in a smartphone.

Reaching: Patients with paralysis from spinal cord injury sometimescannot extend their elbow to reach above the head. Application of aSmart Band Aid™ to the triceps muscle stimulates this muscle to extendthe elbow. This is triggered by a sensor in the Smart Band Aid™detecting arm movements and coordinating it with an application on asmartphone.

Posture: People whose trunk muscles are paralyzed may have difficultymaintaining their posture even in a wheelchair. They may fall forwardunless they wear a seatbelt, and if they lean forward they may be unableto regain upright posture. Electrical stimulation of the muscles of thelower back using a Smart Band Aid™ allows them to maintain and regainupright posture. Sensors in the Smart Band Aid™ trigger this stimulationwhen a change in posture was detected.

Coughing: People whose abdominal muscles are paralyzed cannot produce astrong cough and are at risk for pneumonia. Stimulation of the musclesof the abdominal wall using a Smart Band Aid™ could produce a moreforceful cough and prevent chest infections. The patient using a sensorin a Smart Band Aid™ triggers the stimulation.

Essential Tremor: It has been demonstrated that neuro stimulation canreduce or eliminate the signs of ET. ET may be controlled using a TNSS.A sensor on a Smart Band Aid™ detects the tremor and trigger neurostimulation to the muscles and sensory nerves involved in the tremorwith an appropriate frequency and phase relationship to the tremor. Thestimulation frequency is typically be at the same frequency as thetremor but shifted in phase in order to cancel the tremor or reset theneural control system for hand position.

Non-Medical Applications

Sports Training

Sensing the position and orientation of multiple limb segments is usedto provide visual feedback on a smartphone of, for example, a golfswing, and also mechanical or electrical feedback to the user atparticular times during the swing to show them how to change theiractions. The electromyogram of muscles could also be recorded from oneor many Smart Band Aids™ and used for more detailed analysis.

Gaming

Sensing the position and orientation of arms, legs and the rest of thebody produces a picture of an onscreen player that can interact withother players anywhere on the Internet. Tactile feedback would beprovided to players by actuators in Smart Band Aids on various parts ofthe body to give the sensation of striking a ball, etc.

Motion Capture for Film and Animation

Wireless TNSS capture position, acceleration, and orientation ofmultiple parts of the body. This data may be used for animation of ahuman or mammal and has application for human factor analysis anddesign.

Sample Modes of Operation

A SBA system consists of at least a single Controller and a single SBA.Following application of the SBA to the user's skin, the user controlsit via the

Controller's app using Near Field Communications. The app appears on asmartphone screen and can be touch controlled by the user; for ‘key fob’type Controllers. The SBA is controlled by pressing buttons on the keyfob.

When the user feels the need to activate the SBA s/he presses the “go”button two or more times to prevent false triggering, thus deliveringthe neuro stimulation. The neuro stimulation may be delivered in avariety of patterns of frequency, duration, and strength and maycontinue until a button is pressed by the user or may be delivered for alength of time set in the application.

Sensor capabilities in the TNSS, are enabled to startcollecting/analyzing data and communicating with the controller whenactivated.

The level of functionality in the protocol app, and the protocolembedded in the TNSS, will depend upon the neuro modulation or neurostimulation regimen being employed.

In some cases there will be multiple TNSSs employed for the neuromodulation or neuro stimulation regimen. The basic activation will bethe same for each TNSS.

However, once activated multiple TNSSs will automatically form a networkof neuro modulation/stimulation points with communications enabled withthe controller.

The need for multiple TNSSs arises from the fact that treatment regimensmay need several points of access to be effective.

Controlling the Stimulation

In general, advantages of a wireless TNSS system as disclosed hereinover existing transcutaneous electrical nerve stimulation devicesinclude: (1) fine control of all stimulation parameters from a remotedevice such as a smartphone, either directly by the user or by storedprograms; (2) multiple electrodes of a TNSS can form an array to shapean electric field in the tissues; (3) multiple TNSS devices can form anarray to shape an electric field in the tissues; (4) multiple TNSSdevices can stimulate multiple structures, coordinated by a smartphone;(5) selective stimulation of nerves and other structures at differentlocations and depths in a volume of tissue; (6) mechanical, acoustic oroptical stimulation in addition to electrical stimulation; (7) thetransmitting antenna of TNSS device can focus a beam of electromagneticenergy within tissues in short bursts to activate nerves directlywithout implanted devices; (8) inclusion of multiple sensors of multiplemodalities, including but not limited to position, orientation, force,distance, acceleration, pressure, temperature, voltage, light and otherelectromagnetic radiation, sound, ions or chemical compounds, making itpossible to sense electrical activities of muscles (EMG, EKG),mechanical effects of muscle contraction, chemical composition of bodyfluids, location or dimensions or shape of an organ or tissue bytransmission and receiving of ultrasound.

Further advantages of the wireless TNSS system include: (1) TNSS devicesare expected to have service lifetimes of days to weeks and theirdisposability places less demand on power sources and batteryrequirements; (2) the combination of stimulation with feedback fromartificial or natural sensors for closed loop control of musclecontraction and force, position or orientation of parts of the body,pressure within organs, and concentrations of ions and chemicalcompounds in the tissues; (3) multiple TNSS devices can form a networkwith each other, with remote controllers, with other devices, with theInternet and with other users; (4) a collection of large amounts of datafrom one or many TNSS devices and one or many users regarding sensingand stimulation, collected and stored locally or through the internet;(5) analysis of large amounts of data to detect patterns of sensing andstimulation, apply machine learning, and improve algorithms andfunctions; (6) creation of databases and knowledge bases of value; (7)convenience, including the absence of wires to become entangled inclothing, showerproof and sweat proof, low profile, flexible,camouflaged or skin colored, (8) integrated power, communications,sensing and stimulating inexpensive disposable TNSS, consumableelectronics; (9) power management that utilizes both hardware andsoftware functions will be critical to the convenience factor andwidespread deployment of TNSS device.

Referring again to FIG. 1 , a nerve cell normally has a voltage acrossthe cell membrane of 70 millivolts with the interior of the cell at anegative voltage with respect to the exterior of the cell. This is knownas the resting potential and it is normally maintained by metabolicreactions which maintain different concentrations of electrical ions inthe inside of the cell compared to the outside. Ions can be actively“pumped” across the cell membrane through ion channels in the membranethat are selective for different types of ion, such as sodium andpotassium. The channels are voltage sensitive and can be opened orclosed depending on the voltage across the membrane. An electric fieldproduced within the tissues by a stimulator can change the normalresting voltage across the membrane, either increasing or decreasing thevoltage from its resting voltage.

Referring again to FIG. 2 , a decrease in voltage across the cellmembrane to about 55 millivolts opens certain ion channels, allowingions to flow through the membrane in a self-catalyzing but self-limitedprocess which results in a transient decrease of the trans membranepotential to zero, and even positive, known as depolarization followedby a rapid restoration of the resting potential as a result of activepumping of ions across the membrane to restore the resting situationwhich is known as repolarization. This transient change of voltage isknown as an action potential and it typically spreads over the entiresurface of the cell. If the shape of the cell is such that it has a longextension known as an axon, the action potential spreads along thelength of the axon. Axons that have insulating myelin sheaths propagateaction potentials at much higher speeds than those axons without myelinsheaths or with damaged myelin sheaths.

If the action potential reaches a junction, known as a synapse, withanother nerve cell, the transient change in membrane voltage results inthe release of chemicals known as neuro-transmitters that can initiatean action potential in the other cell. This provides a means of rapidelectrical communication between cells, analogous to passing a digitalpulse from one cell to another.

If the action potential reaches a synapse with a muscle cell it caninitiate an action potential that spreads over the surface of the musclecell. This voltage change across the membrane of the muscle cell opension channels in the membrane that allow ions such as sodium, potassiumand calcium to flow across the membrane, and can result in contractionof the muscle cell.

Increasing the voltage across the membrane of a cell below −70millivolts is known as hyper-polarization and reduces the probability ofan action potential being generated in the cell. This can be useful forreducing nerve activity and thereby reducing unwanted symptoms such aspain and spasticity

The voltage across the membrane of a cell can be changed by creating anelectric field in the tissues with a stimulator. It is important to notethat action potentials are created within the mammalian nervous systemby the brain, the sensory nervous system or other internal means. Theseaction potentials travel along the body's nerve “highways”. The TNSScreates an action potential through an externally applied electric fieldfrom outside the body. This is very different than how action potentialsare naturally created within the body.

Electric Fields that can Cause Action Potentials

Referring to FIG. 2 , electric fields capable of causing actionpotentials can be generated by electronic stimulators connected toelectrodes that are implanted surgically in close proximity to thetarget nerves. To avoid the many issues associated with implanteddevices, it is desirable to generate the required electric fields byelectronic devices located on the surface of the skin. Such devicestypically use square wave pulse trains of the form shown in FIG. 20 .Such devices may be used instead of implants and/or with implants suchas reflectors, conductors, refractors, or markers for tagging targetnerves and the like, so as to shape electric fields to enhance nervetargeting and/or selectivity.

Referring to FIG. 20 , the amplitude of the pulses “A”, applied to theskin, may vary between 1 and 100 Volts, pulse width “t”, between 100microseconds and 10 milliseconds, duty cycle (t/T) between 0.1% and 50%,the frequency of the pulses within a group between 1 and 100/sec, andthe number of pulses per group “n”, between 1 and several hundred.Typically, pulses applied to the skin will have an amplitude of up to 60volts, a pulse width of 250 microseconds and a frequency of 20 persecond, resulting in a duty cycle of 0.5%. In some cases balanced-chargebiphasic pulses will be used to avoid net current flow. Referring toFIG. 21 , these pulses may be symmetrical, with the shape of the firstpart of the pulse similar to that of the second part of the pulse, orasymmetrical, in which the second part of the pulse has lower amplitudeand a longer pulse width in order to avoid canceling the stimulatoryeffect of the first part of the pulse.

Formation of Electric Fields by Stimulators

The location and magnitude of the electric potential applied to thetissues by electrodes provides a method of shaping the electrical field.For example, applying two electrodes to the skin, one at a positiveelectrical potential with respect to the other, can produce a field inthe underlying tissues such as that shown in the cross-sectional diagramof FIG. 22 .

The diagram in FIG. 22 assumes homogeneous tissue. The voltage gradientis highest close to the electrodes and lower at a distance from theelectrodes. Nerves are more likely to be activated close to theelectrodes than at a distance. For a given voltage gradient, nerves oflarge diameter are more likely to be activated than nerves of smallerdiameter. Nerves whose long axis is aligned with the voltage gradientare more likely to be activated than nerves whose long axis is at rightangles to the voltage gradient.

Applying similar electrodes to a part of the body in which there are twolayers of tissue of different electrical resistivity, such as fat andmuscle, can produce a field such as that shown in FIG. 23 . Layers ofdifferent tissue may act to refract and direct energy waves and be usedfor beam aiming and steering. An individual's tissue parameters may bemeasured and used to characterize the appropriate energy stimulation fora selected nerve.

Referring to FIG. 24 , when the stimulating pulse is turned off theelectric field will collapse and the fields will be absent as shown. Itis the change in electric field that will cause an action potential tobe created in a nerve cell, provided sufficient voltage and the correctorientation of the electric field occurs. More complex three-dimensionalarrangements of tissues with different electrical properties can resultin more complex three-dimensional electric fields, particularly sincetissues have different electrical properties and these properties aredifferent along the length of a tissue and across it, as shown in Table1.

TABLE 1 Electrical Conductivity (siemens/m) Direction Average Blood .65Bone Along .17 Bone Mixed .095 Fat .05 Muscle Along .127 Muscle Across.45 Muscle Mixed .286 Skin (Dry) .000125 Skin (Wet) .00121

Modification of Electric Fields by Tissue

An important factor in the formation of electric fields used to createaction potentials in nerve cells is the medium through which theelectric fields must penetrate. For the human body this medium includesvarious types of tissue including bone, fat, muscle, and skin. Each ofthese tissues possesses different electrical resistivity or conductivityand different capacitance and these properties are anisotropic. They arenot uniform in all directions within the tissues. For example, an axonhas lower electrical resistivity along its axis than perpendicular toits axis. The wide range of conductivities is shown in Table 1. Thethree-dimensional structure and resistivity of the tissues willtherefore affect the orientation and magnitude of the electric field atany given point in the body.

Modification of Electric Fields by Multiple Electrodes

Applying a larger number of electrodes to the skin can also produce morecomplex three-dimensional electrical fields that can be shaped by thelocation of the electrodes and the potential applied to each of them.Referring to FIG. 20 , the pulse trains can differ from one anotherindicated by A, t/T, n, and f as well as have different phaserelationships between the pulse trains. For example with an 8×8 array ofelectrodes, combinations of electrodes can be utilized ranging fromsimple dipoles, to quadripoles, to linear arrangements, to approximatelycircular configurations, to produce desired electric fields withintissues.

Applying multiple electrodes to a part of the body with complex tissuegeometry will thus result in an electric field of a complex shape. Theinteraction of electrode arrangement and tissue geometry can be modeledusing Finite Element Modeling, which is a mathematical method ofdividing the tissues into many small elements in order to calculate theshape of a complex electric field. This can be used to design anelectric field of a desired shape and orientation to a particular nerve.

High frequency techniques known for modifying an electric field, such asthe relation between phases of a beam, cancelling and reinforcing byusing phase shifts, may not apply to application of electric fields byTNSSs because they use low frequencies. Instead, examples use beamselection to move or shift or shape an electric field, also described asfield steering or field shaping, by activating different electrodes,such as from an array of electrodes, to move the field. Selectingdifferent combinations of electrodes from an array may result in beam orfield steering. A particular combination of electrodes may shape a beamand/or change the direction of a beam by steering. This may shape theelectric field to reach a target nerve selected for stimulation.

Activation of Nerves by Electric Fields

Typically, selectivity in activating nerves has required electrodes tobe implanted surgically on or near nerves. Using electrodes on thesurface of the skin to focus activation selectively on nerves deep inthe tissues, as with examples of the invention, has many advantages.These include avoidance of surgery, avoidance of the cost of developingcomplex implants and gaining regulatory approval for them, and avoidanceof the risks of long-term implants.

The features of the electric field that determine whether a nerve willbe activated to produce an action potential can be modeledmathematically by the “Activating Function” disclosed in Rattay F., “Thebasic mechanism for the electrical stimulation of the nervous system”,Neuroscience Vol. 89, No. 2, pp. 335-346 (1999). The electric field canproduce a voltage, or extracellular potential, within the tissues thatvaries along the length of a nerve. If the voltage is proportional todistance along the nerve, the first order spatial derivative will beconstant and the second order spatial derivative will be zero. If thevoltage is not proportional to distance along the nerve, the first orderspatial derivative will not be constant and the second order spatialderivative will not be zero. The Activating Function is proportional tothe second-order spatial derivative of the extracellular potential alongthe nerve. If it is sufficiently greater than zero at a given point itpredicts whether the electric field will produce an action potential inthe nerve at that point. This prediction may be input to a nervesignature.

In practice, this means that electric fields that are varyingsufficiently greatly in space or time can produce action potentials innerves. These action potentials are also most likely to be producedwhere the orientation of the nerves to the fields change, either becausethe nerve or the field changes direction. The direction of the nerve canbe determined from anatomical studies and imaging studies such as MRIscans. The direction of the field can be determined by the positions andconfigurations of electrodes and the voltages applied to them, togetherwith the electrical properties of the tissues. As a result, it ispossible to activate certain nerves at certain tissue locationsselectively while not activating others.

To accurately control an organ or muscle, the nerve to be activated mustbe accurately selected. This selectivity may be improved by usingexamples disclosed herein as a nerve signature, in several ways, asfollows:

-   -   (1) Improved algorithms to control the effects when a nerve is        stimulated, for example, by measuring the resulting electrical        or mechanical activity of muscles and feeding back this        information to modify the stimulation and measuring the effects        again. Repeated iterations of this process can result in        optimizing the selectivity of the stimulation, either by        classical closed loop control or by machine learning techniques        such as pattern recognition and artificial intelligence;    -   (2) Improving nerve selectivity by labeling or tagging nerves        chemically; for example, introduction of genes into some nerves        to render them responsive to light or other electromagnetic        radiation can result in the ability to activate these nerves and        not others when light or electromagnetic radiation is applied        from outside the body;    -   (3) Improving nerve selectivity by the use of electrical        conductors to focus an electric field on a nerve; these        conductors might be implanted, but could be passive and much        simpler than the active implantable medical devices currently        used;    -   (4) The use of reflectors or refractors, either outside or        inside the body, is used to focus a beam of electromagnetic        radiation on a nerve to improve nerve selectivity. If these        reflectors or refractors are implanted, they may be passive and        much simpler than the active implantable medical devices        currently used;    -   (5) Improving nerve selectivity by the use of feedback from the        person upon whom the stimulation is being performed; this may be        an action taken by the person in response to a physical        indication such as a muscle activation or a feeling from one or        more nerve activations;    -   (6) Improving nerve selectivity by the use of feedback from        sensors associated with the TNSS, or separately from other        sensors, that monitor electrical activity associated with the        stimulation; and    -   (7) Improving nerve selectivity by the combination of feedback        from both the person or sensors and the TNSS that may be used to        create a unique profile of the user's nerve physiology for        selected nerve stimulation.

Potential applications of electrical stimulation to the body, aspreviously disclosed, are shown in FIG. 15 .

Referring to FIG. 25A, a TNSS 934 human and mammalian interface and itsmethod of operation and supporting system are managed by a MasterControl Program (“MCP”) 910 represented in function format as blockdiagrams. It provides the logic for the nerve stimulator system inaccordance to one example.

In one example, MCP 910 and other components shown in FIG. 25A areimplemented by one or more processors that are executing instructions.The processor may be any type of general or specific purpose processor.Memory is included for storing information and instructions to beexecuted by the processor. The memory can be comprised of anycombination of random access memory (“RAM”), read only memory (“ROM”),static storage such as a magnetic or optical disk, or any other type ofcomputer readable media.

Master Control Program

The primary responsibility of MCP 910 is to coordinate the activitiesand communications among the various control programs, a Data Manager920, a User 932, and the external ecosystem and to execute theappropriate response algorithms in each situation. The MCP 910accomplishes electric field shaping and/or beam steering by providing anelectrode activation pattern to TNSS device 934 to selectively stimulatea target nerve. For example, upon notification by a CommunicationsController 930 of an external event or request, the MCP 910 isresponsible for executing the appropriate response, and working with theData Manager 920 to formulate the correct response and actions. Itintegrates data from various sources such as Sensors 938 and externalinputs such as TNSS devices 934, and applies the correct security andprivacy policies, such as encryption and HIPAA required protocols. Itwill also manage the User Interface (UI) 912 and the various ApplicationProgram Interfaces (APIs) 914 that provide access to external programs.

MCP 910 is also responsible for effectively managing power consumptionby TNSS device 934 through a combination of software algorithms andhardware components that may include, among other things: computing,communications, and stimulating electronics, antenna, electrodes,sensors, and power sources in the form of conventional or printedbatteries.

Communications Controller

Communications controller 930 is responsible for receiving inputs fromthe User 932, from a plurality of TNSS devices 934, and from 3rd partyapps 936 via communications sources such as the Internet or cellularnetworks. The format of such inputs will vary by source and must bereceived, consolidated, possibly reformatted, and packaged for the DataManager 920.

User inputs may include simple requests for activation of TNSS devices934 to status and information concerning the User's 932 situation orneeds. TNSS devices 934 will provide signaling data that may includevoltage readings, TNSS 934 status data, responses to control programinquiries, and other signals. Communications Controller 930 is alsoresponsible for sending data and control requests to the plurality ofTNSS devices 934. 3rd party applications 936 can send data, requests, orinstructions for the Master Control Program 910 or User 932 via theInternet or cellular networks. Communications Controller 930 is alsoresponsible for communications via the cloud where various softwareapplications may reside.

In one example, a user can control one or more TNSS devices using aremote fob or other type of remote device and a communication protocolsuch as Bluetooth. In one example, a mobile phone is also incommunication and functions as a central device while the fob and TNSSdevice function as peripheral devices. In another example, the TNSSdevice functions as the central device and the fob is a peripheraldevice that communicates directly with the TNSS device (i.e., a mobilephone or other device is not needed).

Data Manager

The Data Manager (DM) 920 has primary responsibility for the storage andmovement of data to and from the Communications Controller 930, Sensors938, Actuators 940, and the Master Control Program 910. The DM 920 hasthe capability to analyze and correlate any of the data under itscontrol. It provides logic to select and activate nerves. Examples ofsuch operations upon the data include: statistical analysis and trendidentification; machine learning algorithms; signature analysis andpattern recognition, correlations among the data within the DataWarehouse 926, the Therapy Library 922, the Tissue Models 924, and theElectrode Placement Models 928, and other operations. There are severalcomponents to the data that is under its control as disclosed below.

The Data Warehouse (DW) 926 is where incoming data is stored; examplesof this data can be real-time measurements from TNSS devices 934 or fromSensors (938), data streams from the Internet, or control andinstructional data from various sources. The DM 920 will analyze data,as described above, that is held in the DW 926 and cause actions,including the export of data, under MCP 910 control. Certain decisionmaking processes implemented by the DM 920 will identify data patternsboth in time, frequency, and spatial domains and store them assignatures for reference by other programs. Techniques such as EMG, ormulti-electrode EMG, gather a large amount of data that is the sum ofhundreds to thousands of individual motor units and the typicalprocedure is to perform complex decomposition analysis on the totalsignal to attempt to tease out individual motor units and theirbehavior. The DM 920 will perform big data analysis over the totalsignal and recognize patterns that relate to specific actions or evenindividual nerves or motor units. This analysis can be performed overdata gathered in time from an individual, or over a population of TNSSUsers.

The Therapy Library 922 contains various control regimens for the TNSSdevices 934. Regimens specify the parameters and patterns of pulses tobe applied by the TNSS devices 934. The width and amplitude ofindividual pulses may be specified to stimulate nerve axons of aparticular size selectively without stimulating nerve axons of othersizes. The frequency of pulses applied may be specified to modulate somereflexes selectively without modulating other reflexes. There are presetregimens that may be loaded from the Cloud 942 or 3rd party apps 936.The regimens may be static read-only as well as adaptive with read-writecapabilities so they can be modified in real-time responding to controlsignals or feedback signals or software updates. Referring to FIG. 3 ,one such example of a regimen has parameters A=40 volts, t=500microseconds, T=1 Millisecond, n=100 pulses per group, and f=20 persecond. Other examples of regimens will vary the parameters withinranges previously specified.

The Tissue Models 924 is specific to the electrical properties ofparticular body locations where TNSS devices 934 may be placed. Aspreviously disclosed, electric fields for production of actionpotentials will be affected by the different electrical properties ofthe various tissues that they encounter. Tissue Models 924 are combinedwith regimens from the Therapy Library 922 and Electrode PlacementModels 928 to produce desired actions. Tissue Models 924 may bedeveloped by MRI, Ultrasound or other imaging or measurement of tissueof a body or particular part of a body. This may be accomplished for aparticular User 932 and/or based upon a body norm. One such example of adesired action is the use of a Tissue Model 924 together with aparticular Electrode Placement Model 928 to determine how to focus theelectric field from electrodes on the surface of the body on a specificdeep location corresponding to the pudendal nerve in order to stimulatethat nerve selectively to reduce incontinence of urine. Other examplesof desired actions may occur when a Tissue Model 924 in combination withregimens from the Therapy Library 22 and Electrode Placement Models 928produce an electric field that stimulates a sacral nerve. Many otherexamples of desired actions follow for the stimulation of other nerves.

Electrode Placement Models 928 specify electrode configurations that theTNSS devices 934 may apply and activate in particular locations of thebody. For example, a TNSS device 934 may have multiple electrodes andthe Electrode Placement Model 928 specifies where these electrodesshould be placed on the body and which of these electrodes should beactive in order to stimulate a specific structure selectively withoutstimulating other structures, or to focus an electric field on a deepstructure. An example of an electrode configuration is a 4 by 4 set ofelectrodes within a larger array of multiple electrodes, such as an 8 by8 array. This 4 by 4 set of electrodes may be specified anywhere withinthe larger array such as the upper right corner of the 8 by 8 array.Other examples of electrode configurations may be circular electrodesthat may even include concentric circular electrodes. The TNSS device934 may contain a wide range of multiple electrodes of which theElectrode Placement Models 928 will specify which subset will beactivated. The Electrode Placement Models 928 complement the regimens inthe Therapy Library 922 and the Tissue Models 924 and are used togetherwith these other data components to control the electric fields andtheir interactions with nerves, muscles, tissues and other organs. Otherexamples may include TNSS devices 934 having merely one or twoelectrodes, such as but not limited to those utilizing a closed circuit.

Sensor/Actuator Control

Independent sensors 938 and actuators 940 can be part of the TNSSsystem. Its functions can complement the electrical stimulation andelectrical feedback that the TNSS devices 934 provide. An example ofsuch a sensor 938 and actuator 940 include, but are not limited to, anultrasonic actuator and an ultrasonic receiver that can providereal-time image data of nerves, muscles, bones, and other tissues. Otherexamples include electrical sensors that detect signals from stimulatedtissues or muscles. The Sensor/Actuator Control module 950 provides theability to control both the actuation and pickup of such signals, allunder control of the MCP 910.

Application Program Interfaces

The MCP 910 is also responsible for supervising the various ApplicationProgram Interfaces (APIs) that will be made available for 3rd partydevelopers. There may exist more than one API 914 depending upon thespecific developer audience to be enabled. For example many statisticalfocused apps will desire access to the Data Warehouse 926 and itscumulative store of data recorded from TNSS 934 and User 932 inputs.Another group of healthcare professionals may desire access to theTherapy Library 922 and Tissue Models 924 to construct better regimensfor addressing specific diseases or disabilities. In each case adifferent specific API 914 may be appropriate.

The MCP 910 is responsible for many software functions of the TNSSsystem including system maintenance, debugging and troubleshootingfunctions, resource and device management, data preparation, analysis,and communications to external devices or programs that exist on thesmart phone or in the cloud, and other functions. However, one of itsprimary functions is to serve as a global request handler taking inputsfrom devices handled by the Communications Controller 930, externalrequests from the Sensor Control Actuator Module (950), and 3rd partyrequests 936. Examples of High Level Master Control Program (MCP)functions are disclosed below.

The manner in which the MCP handles these requests is shown in FIG. 25B.The Request Handler (RH) 960 accepts inputs from the User 932, TNSSdevices 934, 3rd party apps 936, sensors 938 and other sources. Itdetermines the type of request and dispatches the appropriate responseas set forth in the following paragraphs.

User Request: The RH 960 will determine which of the plurality of UserRequests 961 is present such as: activation; display status,deactivation, or data input, e.g. specific User condition. Shown in FIG.25B is the RH's 960 response to an activation request. As shown in block962, RH 960 will access the Therapy Library 922 and cause theappropriate regimen to be sent to the correct TNSS 934 for execution, asshown at block 964 labeled “Action.”

TNSS/Sensor Inputs: The RH 960 will perform data analysis over TNSS 934or Sensor inputs 965. As shown at block 966, it employs data analysis,which may include techniques ranging from DSP decision-making processes,image processing algorithms, statistical analysis and other algorithmsto analyze the inputs. In FIG. 25B two such analysis results are shown;conditions which cause a User Alarm 970 to be generated and conditionswhich create an Adaptive Action 980 such as causing a control feedbackloop for specific TNSS 934 functions, which can iteratively generatefurther TNSS 934 or Sensor inputs 965 in a closed feedback loop.

3rd Party Apps: Applications can communicate with the MCP 910, bothsending and receiving communications. A typical communication would beto send informational data or commands to a TNSS 934. The RH 960 willanalyze the incoming application data, as shown at block 972. FIG. 25Bshows two such actions that result. One action, shown at block 974 wouldbe the presentation of the application data, possibly reformatted, tothe User 932 through the MCP User Interface 912. Another result would beto perform a User 932 permitted action, as shown at 976, such asrequesting a regimen from the Therapy Library 922.

Referring to FIG. 26 , an example TNSS in accordance to one example isshown. The TNSS has one or more electronic circuits or chips 2600 thatperform the functions of: communications with the controller, nervestimulation via electrodes 2608 that produce a wide range of electricfield(s) according to treatment regimen, one or more antennae 2610 thatmay also serve as electrodes and communication pathways, and a widerange of sensors 2606 such as, but not limited to, mechanical motion andpressure, temperature, humidity, chemical and positioning sensors. Inanother example, TNSS interfaces to transducers 2614 to transmit signalsto the tissue or to receive signals from the tissue.

One arrangement is to integrate a wide variety of these functions intoan SOC, system on chip 2600. Within this is shown a control unit 2602for data processing, communications, transducer interface and storageand one or more stimulators 2604 and sensors 2606 that are connected toelectrodes 2608. An antenna 2610 is incorporated for externalcommunications by the control unit. Also present is an internal powersupply 2612, which may be, for example, a battery. An external powersupply is another variation of the chip configuration. It may benecessary to include more than one chip to accommodate a wide range ofvoltages for data processing and stimulation. Electronic circuits andchips will communicate with each other via conductive tracks within thedevice capable of transferring data and/or power.

The TNSS interprets a data stream from the control device, such as thatshown in FIG. 25A, to separate out message headers and delimiters fromcontrol instructions. In one example, control instructions containinformation such as voltage level and pulse pattern. The TNSS activatesthe stimulator 2604 to generate a stimulation signal to the electrodes2608 placed on the tissue according to the control instructions. Inanother example the TNSS activates a transducer 2614 to send a signal tothe tissue. In another example, control instructions cause informationsuch as voltage level and pulse pattern to be retrieved from a librarystored in the TNSS.

The TNSS receives sensory signals from the tissue and translates them toa data stream that is recognized by the control device, such as theexample in FIG. 25A. Sensory signals include electrical, mechanical,acoustic, optical and chemical signals among others. Sensory signalscome to the TNSS through the electrodes 2608 or from other inputsoriginating from mechanical, acoustic, optical, or chemical transducers.For example, an electrical signal from the tissue is introduced to theTNSS through the electrodes 2608, is converted from an analog signal toa digital signal and then inserted into a data stream that is sentthrough the antenna 2610 to the control device. In another example anacoustic signal is received by a transducer 2614 in the TNSS, convertedfrom an analog signal to a digital signal and then inserted into a datastream that is sent through the antenna 2610 to the control device. Incertain examples sensory signals from the tissue are directly interfacedto the control device for processing.

An open loop protocol to control current to electrodes in known neuralstimulation devices does not have feedback controls. It commands avoltage to be set, but does not check the actual Voltage. Voltagecontrol is a safety feature. A stimulation pulse is sent based on presetparameters and cannot be modified based on feedback from the patient'sanatomy. When the device is removed and repositioned, the electrodeplacement varies. Also the humidity and temperature of the anatomychanges throughout the day. All these factors affect the actual chargedelivery if the voltage is preset.

In contrast, examples of the TNSS stimulation device have features thataddress these shortcomings using the Nordic Semiconductor nRF52832microcontroller to regulate charge in a TNSS. The High Voltage Supply isimplemented using a LED driver chip combined with a Computer controlledDigital Potentiometer to produce a variable voltage. A 3-1 step upTransformer then provides the desired High Voltage, “VBOOST”, which issampled to assure that no failure causes an incorrect Voltage level asfollows. The nRF52832 Microcontroller samples the voltage of thestimulation waveform providing feedback and impedance calculations foran adaptive protocol to modify the waveform in real time. The Currentdelivered to the anatomy by the stimulation waveform is integrated usinga differential integrator and sampled and then summed to determineactual charge delivered to the user for a Treatment. After every pulsein a Stimulation event, this measurement is analyzed and used to modify,in real time, subsequent pulses.

This hardware adaptation allows a firmware protocol to implement theadaptive protocol. This protocol regulates the charge applied to thebody by changing VBOOST. A treatment is performed by a sequence ofperiodic pulses, which insert charge into the body through theelectrodes. Some of the parameters of the treatment are fixed and someare user adjustable. The strength, duration and frequency may be useradjustable. The user may adjust these parameters as necessary forcomfort and efficacy. The strength may be lowered if there is discomfortand raised if nothing is felt. The duration will be increased if themaximum acceptable strength results in an ineffective treatment.

A flow diagram in accordance with one example of the Adaptive Protocoldisclosed above is shown in FIG. 27 . The Adaptive Protocol strives torepeatedly and reliably deliver a target charge (“Q_(target)”) during atreatment and to account for any environmental changes. Therefore, thefunctionality of FIG. 27 is to adjust the charge level applied to a userbased on feedback, rather than use a constant level.

The mathematical expression of this protocol is as follows:Q_(target)=Q_(target)(A*dS+B*dT), where A is the StrengthCoefficient—determined empirically, dS is the user change in Strength, Bis the Duration Coefficient—determined empirically, and dT is the userchange in Duration.

The Adaptive Protocol includes two phases in one example: Acquisition2700 and Reproduction 2720. Any change in user parameters places theAdaptive Protocol in the Acquisition phase. When the first treatment isstarted, a new baseline charge is computed based on the new parameters.At a new acquisition phase at 2702, all data from the previous chargeapplication is discarded. In one example, 2702 indicates the first timefor the current usage where the user places the TNSS device on a portionof the body and manually adjusts the charge level, which is a series ofcharge pulses, until it feels suitable, or any time the charge level ischanged, either manually or automatically. The treatment then starts.The mathematical expression of this function of the application of acharge is as follows:

The charge delivered in a treatment is

$Q_{target} = {\sum\limits_{i = 1}^{T*f}\;{Q_{pulse}(i)}}$Where T is the duration; f is the frequency of “Rep Rate”; Q_(pulse) (i)is the measured charge delivered by Pulse (i) in the treatment pulsetrain provided as a voltage MON_CURRENT that is the result of aDifferential Integrator circuit shown in FIG. 28 (i.e., the averageamount of charge per pulse). The Nordic microcontroller of FIG. 28 is anexample of an Analog to Digital Conversion feature used to quantifyvoltage into a number representing the delivered charge and thereforedetermine the charge output. The number of pulses in the treatment isT*f.

At 2704 and 2706, every pulse is sampled. In one example, thefunctionality of 2704 and 2706 lasts for 10 seconds with a pulse rate of20 Hz, which can be considered a full treatment cycle. The result ofphase 2700 is the target pulse charge of Q_(target).

FIG. 29 is a table in accordance with one example showing the number ofpulses per treatment measured against two parameters, frequency andduration. Frequency is shown on the Y-axis and duration on the X-axis.The Adaptive Current protocol in general performs better when using morepulses. One example uses a minimum of 100 pulses to provide for solidconvergence of charge data feedback. Referring to the FIG. 29 , afrequency setting of 20 Hz and duration of 10 seconds produces 200pulses, which is desirable to allow the Adaptive Current Protocol toreproduce a previous charge.

The reproduction phase 2720 begins in one example when the userinitiates another subsequent treatment after acquisition phase 2700 andthe resulting acquisition of the baseline charge, Q_(target). Forexample, a full treatment cycle, as discussed above, may take 10seconds. After, for example, a two-hour pause as shown at wait period2722, the user may then initiate another treatment. During this phase,the Adaptive Current Protocol attempts to deliver Q_(target) for eachsubsequent treatment. The functionality of phase 2720 is needed because,during the wait period 2722, conditions such as the impedance of theuser's body due to sweat or air humidity may have changed. Thedifferential integrator is sampled at the end of each Pulse in theTreatment. At that point, the next treatment is started and thedifferential integrator is sampled for each pulse at 2724 for purposesof comparison to the acquisition phase Q_(target). Sampling the pulseincludes measuring the output of the pulse in coulombs. The output ofthe integrator of FIG. 28 in voltage, referred to as Mon_Current 2801,is a direct linear relationship to the delivered charge inmicro-coulombs and provides a reading of how much charge is leaving thedevice and entering the user. At 2726, each single pulse is compared tothe charge value determined in phase 2700 (i.e., the target charge) andthe next pulse will be adjusted in the direction of the difference.NUM_PULSES=(T*f)After each pulse, the observed charge, Q_(pulse)(i), is compared to theexpected charge per pulse.Q _(pulse)(i)>Q _(target)/NUM_PULSES?The output charge or “VBOOST” is then modified at either 2728(decreasing) or 2730 (increasing) for the subsequent pulse by:dV(i)=G[Q _(target)/NUM_PULSES−Q _(pulse)(i)]where G is the Voltage adjustment Coefficient—determined empirically.The process continues until the last pulse at 2732.

A safety feature assures that the VBOOST will never be adjusted higherby more than 10%. If more charge is necessary, then the repetition rateor duration can be increased.

In one example, in general, the current is sampled for every pulseduring acquisition phase 2700 to establish target charge forreproduction. The voltage is then adjusted via a digital potentiometer,herein referred to as “Pot”, during reproduction phase 2720 to achievethe established target_charge.

The digital Pot is calibrated with the actual voltage at startup. Atable is generated with sampled voltage for each wiper value. Tables arealso precomputed storing the Pot wiper increment needed for 1 v and 5 voutput delta at each pot level. This enables quick reference for voltageadjustments during the reproduction phase. The tables may need periodicrecalibration due to battery level.

In one example, during acquisition phase 2700, the minimum data set=100pulses and every pulse is sampled and the average is used as thetarget_charge for reproduction phase 2720. In general, less than 100pulses may provide an insufficient data sample to use as a basis forreproduction phase 2720. In one example, the default treatment is 200pulses (i.e., 20 Hz for 10 seconds). In one example, a user can adjustboth duration and frequency manually.

In one example, during acquisition phase 2700, the maximum data set=1000pulses. The maximum is used to avoid overflow of 32 bit integers inaccumulating the sum of samples. Further, 1000 pulses in one example isa sufficiently large data set and collecting more is likely unnecessary.

After 1000 pulses for the above example, the target_charge is computed.Additional pulses beyond 1000 in the acquisition phase do not contributeto the computation of the target charge.

In one example, the first 3-4 pulses are generally higher than the restso these are not used in acquisition phase 2700. This is also accountedfor in reproduction phase 2720. Using these too high values can resultin target charge being set too high and over stimulating on thesubsequent treatments in reproduction phase 2720. In other examples,more advanced averaging algorithms could be applied to eliminating highand low values.

In an example, there may be a safety concern about automaticallyincreasing the voltage. For example, if there is poor connection betweenthe device and the user's skin, the voltage may auto-adjust at 2730 upto the max. The impedance may then be reduced, for example by the userpressing the device firmly, which may result in a sudden high current.Therefore, in one example, if the sample is 500 mv or more higher thanthe target, it immediately adjusts to the minimum voltage. This examplethen remains in reproduction phase 2720 and should adjust back to thetarget current/charge level. In another example, the maximum voltageincrease is set for a single treatment (e.g., 10V). More than thatshould not be needed in normal situations to achieve the establishedtarget_charge. In another example, a max is set for VBOOST (e.g., 80V).

In various examples, it is desired to have stability during reproductionphase 2720. In one example, this is accomplished by adjusting thevoltage by steps. However, a relatively large step adjustment can resultin oscillation or over stimulation. Therefore, voltage adjustments maybe made in smaller steps. The step size may be based on both the deltabetween the target and sample current as well as on the actual VBOOSTvoltage level. This facilitates a quick and stable/smooth convergence tothe target charge and uses a more gradual adjustments at lower voltagesfor more sensitive users.

The following are the conditions that may be evaluated to determine theadjustment step.delta−mon_current=abs(sample_mon_current−target_charge)

-   -   If delta_mon_current>500 mv and VBOOST>20V then step=5V for        increase adjustments    -   (For decrease adjustments a 500 mv delta triggers emergency        decrease to minimum Voltage)    -   If delta_mon_current>200 mv then step=1V    -   If delta_mon_current>100 mv and        delta_mon_current>5%*sample_mon_current then step=1V

In other examples, new treatments are started with voltage lower thantarget voltage with a voltage buffer of approximately 10%. The impedanceis unknown at the treatment start. These examples save thetarget_voltage in use at the end of a treatment. If the user has notadjusted the strength parameter manually, it starts a new treatment withsaved target_voltage with the 10% buffer. This achieves target currentquickly with the 10% buffer to avoid possible over stimulation in caseimpedance has been reduced. This also compensates for the first 3-4pulses that are generally higher.

As disclosed, examples apply an initial charge level, and thenautomatically adjust based on feedback of the amount of current beingapplied. The charge amount can be varied up or down while being applied.Therefore, rather than setting and then applying a fixed voltage levelthroughout a treatment cycle, implementations of the invention measurethe amount of charge that is being input to the user, and adjustaccordingly throughout the treatment to maintain a target charge levelthat is suitable for the current environment.

Location-Specific Patch

The duration of use and electronic effectiveness of the Topical NerveStimulation and Sensor (TNSS) apparatus as disclosed in examples hereinmay be further optimized by form factor according to specific locationof skin application. Examples include the use of a patch incorporating aTNSS apparatus and designed in a shape to adhere to a specific locationon a person's body, or in a shape to be incorporated into clothing to bein close proximity to a specific location on a person's body, tooptimize the effectiveness of the TNSS.

In FIG. 30 , a tibial patch or TNSS or “SmartPad” 100 in accordance withexamples is designed in a shape to conform to the skin when affixed inthe location below the ankle bone 110 to be effective at stimulating thetibial nerve; and the shape to be of one type for the left ankle, and ofa similar but mirrored type for the right ankle. A SmartPad is moreeffective when the positive and negative electrodes are placed axiallyalong the path of the nerve in contrast to transversely across the pathof the nerve, which is not as effective.

In FIG. 31 , a radial SmartPad 200 is designed in a shape to conform tothe skin when affixed in the location on the forearm to beelectronically effective at stimulating the radial nerve 202; a medianSmartPad 220 is designed in a shape to conform to the skin when affixedin the location on the forearm to be electronically effective atstimulating the median nerve 222; and an ulnar SmartPad 240 is designedto conform to the skin when affixed in the location on the forearm to beelectronically effective at stimulating the ulnar nerve 242.

Each of the SmartPad shapes in FIGS. 30 and 31 is designed to minimizediscomfort for the user when affixed in the target location.

In some examples, two or more of the radial 200, median 220 and ulnarSmartPads 240 may be designed into a larger SmartPad with a shape tocover the locations on the skin corresponding to the two or more ofradial, median and ulnar nerve stimulation electrode pairs, such as abracelet shape 250 surrounding the forearm, or a semi-bracelet 255spanning one side of the forearm, or a bracelet shape with strap 260surrounding the forearm and using a strap 265 to tighten to maintainplacement of electrodes without the need for additional adhesives. Insome examples, these combined SmartPads are designed in one shape forthe left forearm, and a similar but mirrored shape for the rightforearm.

In FIG. 32 , a skin patch 300 includes a SmartPad 340 with TNSS designand packaging disclosed above. SmartPad 340 material is selected to bedisposable after removal from the skin, for example paper, and isselected to inhibit moisture penetration and foreign material intrusionwhich might adversely affect the performance of the TNSS. SmartPad 340is packaged before use between top outer packaging 310, and bottom outerpackaging 320. Top outer packaging incorporates one or more of writing312, illustrations 314, and orientation mark 316, the orientation mark316 being useful for properly positioning the SmartPad 340 on the skin.Bottom outer packaging incorporates one or both of writing 322 andillustrations 324. SmartPad 340 may have removable orientation marking346, initially affixed to the outer surface of the SmartPad 340, thismarking designed to simplify proper orientation of the SmartPad onto thetarget location on the skin and designed to be removed by the user whileleaving the SmartPad in place such that the distinctive marking 346 isno longer seen on the user's skin. SmartPad 340 may have supplementaryadhesive pads 350 of sufficient size and efficacy to maintain adhesionwhen in use but minimize pulling force when removing the SmartPad 340;and adhesive pad covers 330, initially covering the supplementaryadhesive pads 350 and covering the electrodes, the adhesive pad covers330 being removed before affixing the adhesives to the skin; folded pulltabs 332 to facilitate remove of the adhesive film covers 330. SmartPad340 may have non-adhering tab area 344, at one or both ends of theSmartPad, to facilitate grabbing of the SmartPad edge to begin removalof the SmartPad, opposite the adhesive film patches 350. All componentsof SmartPad 340 are coupled to the same substrate in one example.

FIG. 33 illustrates other example locations for a patch.

FIG. 34 illustrates a cutaway view where a right foot plantar sock patch530 is affixed into the sole 520 of a sock 510, using adhesive orstitches, such that the sock patch 530 is effective for stimulationthrough the sole of the user's foot skin and tissue to stimulate theplantar nerve.

In some examples, the sock patch uses a removable battery power supply.In some examples, the sock patch uses a rechargeable battery powersupply and has a recharging port on the sock. In some examples, the sockpatch uses a battery power supply with kinetic power converter.

FIG. 35 illustrates a cutaway view where a right foot plantar shoe patch630 is affixed into the sole 625 of a shoe 615, such that the shoe patch630 is effective for stimulation through the sole of the user's footskin and tissue to stimulate the plantar nerve, particularly whenwearing no intervening clothing layer such as a sock which reduces theeffectiveness of the stimulation.

In some examples, shoe patch 630 uses a removable battery power supply.In some examples, the shoe patch uses a rechargeable battery powersupply and has a recharging port on the shoe. In some examples, the shoepatch uses a battery power supply with kinetic power converter. In someexamples, shoe patch 630 is incorporated into the shoe 615 duringmanufacture of the shoe, the shoe being specifically designed for awearer to use the integral TNSS device.

In some examples, shoe patch 630 is applied to an interior surface of anordinary shoe 610 by the person intending to wear the shoe.

Skin patches designed for specific body locations use different softwarelibraries for their operation, each of which is optimized for the skinpatch location and using a model for the underlying skin, tissue andnerves. An example is a sacral skin patch which involves models for theskin, fat, muscle, bone and nerves specific to the sacrum location, ascompared to an ulnar skin patch which involves models which involvesmodels for the tibial nerve location.

Several examples are specifically illustrated and/or described herein.However, it will be appreciated that modifications and variations of thedisclosed examples are covered by the above teachings and within thepurview of the appended claims without departing from the spirit andintended scope of the invention.

What is claimed is:
 1. A topical nerve stimulation patch comprising: aflexible substrate; a dermis conforming bottom surface of the substratecomprising adhesive and adapted to contact the dermis; a flexible topouter surface of the substrate approximately parallel to the bottomsurface; a plurality of electrodes positioned on the patch proximal tothe bottom surface and located beneath the top outer surface anddirectly coupled to the flexible substrate; and electronic circuitryembedded in the patch and located beneath the top outer surface anddirectly coupled to the flexible substrate, the electronic circuitrycomprising: a control unit configured to implement a nerve stimulationtreatment on a user; an electrical signal generator configured toelectrically activate the electrodes; an antenna in communication withthe electrical signal generator; and a power source in electricalcommunication with the electrical signal generator, the antenna and thesignal activator; the nerve stimulation treatment comprising: determinea target charge level to be applied to the user; output a series ofpulses from the electrodes; for some or all of each pulse outputted,measure, using the electronic circuitry, a charge value of the pulse asapplied to the user and compare the charge value to the target chargelevel; if the charge value is greater than the target charge level,reduce a strength level of a subsequent outputted pulse; and if thecharge value is less than the target charge level, increasing thestrength level of a subsequent outputted pulse.
 2. The topical nervestimulation patch of claim 1, the electronic circuitry furthercomprising a nerve stimulation sensor that provides feedback in responseto a stimulation of one or more nerves and is directly coupled to theflexible substrate.
 3. The topical nerve stimulation patch of claim 2,the antenna configured to communicate with a remote activation device;the electrical signal generator configured to generate one or moreelectrical stimuli in response to initiation by the control unit; theelectrical stimuli configured to stimulate one or more nerves of theuser wearing the nerve stimulation patch at least at one locationproximate to the patch.
 4. The topical nerve stimulation patch of claim1, in which the series of pulses are defined based on a frequency andduration.
 5. The topical nerve stimulation patch of claim 1, in whichdetermining the target charge level Q_(target) comprises generating anacquisition series of pulses and${Q_{target} = {\sum\limits_{i = 1}^{T*f}{Q_{pulse}(i)}}},$ where T is aduration of the acquisition series of pulses, f is a frequency of theacquisition series of pulses and Q_(pulse) (i) is a measured charge ofeach of the acquisition series of pulses.
 6. The topical nervestimulation patch of claim 1, the electronic circuitry furthercomprising a differential integrator, the charge value of the pulsebased on an output of the differential integrator.
 7. The topical nervestimulation patch of claim 3, further comprising a shape of the patchthat is based on the location of the patch on the user and causes theelectrodes to generally be arranged along an axis of the nerves to bestimulated.
 8. The topical nerve stimulation patch of claim 1, the nervestimulation treatment configured for treating an overactive bladder, andgenerating a current between about 20 mA and 100 mA during use.
 9. Thetopical nerve stimulation patch of claim 8, the series of pulsescomprising voltage regulated waves comprising square waves, the squareswaves comprising a frequency between approximately 15 Hz and 50 Hz. 10.The topical nerve stimulation patch of claim 3, the remote activationdevice comprising a FOB and depressing a button on the FOB activates thesignal generator of the patch.
 11. A method of using a topical nervestimulation system patch for electrical stimulation, the methodcomprising: applying the patch to a dermis of a user using adhesive, thepatch comprising: a flexible substrate; a dermis conforming bottomsurface of the substrate comprising adhesive and adapted to contact thedermis; a flexible top outer surface of the substrate approximatelyparallel to the bottom surface; a plurality of electrodes positioned onthe patch proximal to the bottom surface and located beneath the topouter surface and directly coupled to the flexible substrate; andelectronic circuitry embedded in the patch and located beneath the topouter surface and directly coupled to the flexible substrate, theelectronic circuitry comprising: a control unit configured to implementa nerve stimulation treatment on a user; an electrical signal generatorconfigured to electrically activate the electrodes; an antenna incommunication with the electrical signal generator; and a power sourcein electrical communication with the electrical signal generator, theantenna and the signal activator; the nerve stimulation treatmentcomprising: determining a target charge level; outputting a series ofpulses from the electrodes; for some or all of each pulse outputted,measuring, using the electronic circuitry, a charge value of the pulseand compare the charge value to the target charge level; if the chargevalue is greater than the target charge level, reducing a strength levelof a subsequent outputted pulse; and if the charge value is less thanthe target charge level, increasing the strength level of a subsequentoutputted pulse.
 12. The method of claim 11, further comprisingproviding feedback by a nerve stimulation sensor that provides thefeedback in response to a stimulation of one or more nerves and isdirectly coupled to the flexible substrate.
 13. The method of claim 11,the antenna configured to communicate with a remote activation device;the electrical signal generator configured to generate one or moreelectrical stimuli in response to initiation by the control unit; theelectrical stimuli configured to stimulate one or more nerves of theuser wearing the nerve stimulation patch at least at one locationproximate to the patch.
 14. The method of claim 11, in which the seriesof pulses are defined based on a frequency and a duration.
 15. Themethod of claim 11, in which determining the target charge levelQ_(target) comprises generating an acquisition series of pulses and${Q_{target} = {\sum\limits_{i = 1}^{T*f}{Q_{pulse}(i)}}},$ where T is aduration of the acquisition series of pulses, f is a frequency of theacquisition series of pulses and Q_(pulse) (i) is a measured charge ofeach of the acquisition series of pulses.
 16. The method of claim 11,the electronic circuitry further comprising a differential integrator,the charge value of the pulse based on an output of the differentialintegrator.
 17. The method of claim 13, further comprising a shape ofthe patch that is based on the location of the patch on the user andcauses the electrodes to generally be arranged along an axis of thenerves to be stimulated.
 18. The method of claim 11, the nervestimulation treatment configured for treating an overactive bladder, andgenerating a current between about 20 mA and 100 mA during use.
 19. Themethod of claim 11, the series of pulses comprising voltage regulatedwaves comprising square waves, the squares waves comprising a frequencybetween approximately 15 Hz and 50 Hz.
 20. The method of claim 13, theremote activation device comprising a FOB and depressing a button on theFOB activates the signal generator of the patch.